Actively Recruiting

Age: 35Years - 80Years
All Genders
NCT07336199

Pairing Subjective Patient Rating and DBS Programming

Led by Ludwig-Maximilians - University of Munich · Updated on 2026-01-14

25

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

L

Ludwig-Maximilians - University of Munich

Lead Sponsor

M

Medtronic

Collaborating Sponsor

AI-Summary

What this Trial Is About

This multicenter, prospective and retrospective diagnostic study investigates personalized programming strategies for deep brain stimulation (DBS) in patients with Parkinson's disease. DBS of the subthalamic nucleus (STN) is an established therapy for advanced Parkinson's disease; however, optimization of stimulation parameters remains time-consuming and resource-intensive due to the growing complexity of electrode designs and programming options. The PERCEPT-DBS study aims to improve DBS programming by combining subjective patient-reported outcomes with objective electrophysiological biomarkers. Specifically, the study examines the relationship between patients' subjective assessment of stimulation efficacy, measured using a visual analogue scale (VAS), and local field potentials (LFPs), with a focus on beta-band activity recorded from implanted DBS electrodes. These data are integrated with structural and functional neuroimaging to identify individualized stimulation "sweet spots" within the STN. A total of 24 patients with idiopathic Parkinson's disease treated with bilateral STN-DBS will be recruited across several German DBS centers. Participants undergo standardized clinical assessments, VAS-based blinded monopolar reviews, and LFP recordings using sensing-enabled implantable pulse generators. In addition, imaging-based analyses are performed to relate electrophysiological and subjective measures to anatomical and connectomic features. The primary objective is to determine whether electrophysiological markers correlate with subjective patient ratings and whether their overlap defines personalized optimal stimulation targets. By integrating patient perception with neurophysiological and imaging data, this study seeks to advance individualized DBS programming strategies and contribute to the development of more efficient, patient-centered, and potentially adaptive DBS therapies.

CONDITIONS

Official Title

Pairing Subjective Patient Rating and DBS Programming

Who Can Participate

Age: 35Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 35 and 80 years
  • Clinically confirmed idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria
  • Status post bilateral deep brain stimulation of the subthalamic nucleus (STN-DBS)
  • Implanted DBS system suitable for electrophysiological recordings (prospective cohort: sensing-enabled implantable pulse generator)
  • Ability to understand study procedures and communicate reliably with the investigator
  • Written informed consent provided
Not Eligible

You will not qualify if you...

  • Any condition impairing the ability to provide informed consent or comply with study procedures
  • Presence of exclusion criteria for Parkinson's disease according to Movement Disorder Society (MDS) criteria
  • Manifest dementia according to ICD-10 criteria
  • Severe neurological, psychiatric, or medical conditions interfering with study participation or assessments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

LMU University Hospital

München, Germany, 81377

Actively Recruiting

Loading map...

Research Team

T

Thomas Köglsperger, PD Dr. med., MHBA

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Pairing Subjective Patient Rating and DBS Programming | DecenTrialz